Tracheostomy in ICU With a Double Lumen Endotracheal Tube

Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube

Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. This situation may lead to many disadvantages for ventilation and airway protection of critically ill patients during the procedures. The use of double lumen endotracheal tube dedicated to the percutaneous tracheostomies may:

1. improve the ventilation of patients during the procedure,
2. protect the posterior tracheal wall from damage related to the different step of tracheostomies,
3. protect the lungs from blood and secretions coming down from the chosen site of tracheostomy.

So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen endotracheal tube.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Acute Respiratory Failure; Neurological Disease
• Intervention / Treatment: Device: Double lumen endotracheal tube tracheostomy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genoa, Italy, 16132
    • Recruiting
    • University of Genoa
    • Contact: Paolo Pelosi, Professor; Phone Number: + 39 0101 5553136; Email: ppelosi@hotmail.com
    • Principal Investigator: Paolo Pelosi, Professor
    • Sub-Investigator: Maria Vargas, MD
  • Naples, Italy, 80100
    • Recruiting
    • University of Naples "Federico II"
    • Contact: Giuseppe Servillo, Professor; Phone Number: +39 081 7463552; Email: servillo@unina.it
    • Principal Investigator: Giuseppe Servillo, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age ≥ 18 years and at least one of following criteria:
• prolonged endotracheal intubation
• prolonged mechanical ventilation
• difficult/prolonged weaning
• inability to protect the airway

Exclusion Criteria:

• infection of neck tissues
• previous surgical neck interventions
• recent surgical interventions or fracture of the cervical spine

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Double lumen endotracheal tube tracheostomy; Tracheostomy with a dedicated double lumen endotracheal tube

Device: Double lumen endotracheal tube tracheostomy; Percutaneous tracheostomy in this study will be performed with the use of a dedicated double-lumen endotracheal tube. The dedicated double-lumen endotracheal tube (Deas S.R.L, Italy) has an upper and a lower lumen. The upper one will be occupied by flexible fiberoptic bronchoscope while the lower one is exclusively dedicated to patient ventilation during the procedure. The lower lumen has a a semi-elliptical cross section. This tube will be placed in the patient airway with a direct laryngoscopy. After this intubation, a percutaneous dilatational tracheostomy will be performed with the standard techniques recognised in the literature.; Other Names: International Patent n° PCT/IT2012/000154

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in gas-exchange	The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio	at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in arterial carbon dioxide	the investigator will perform an arterial blood gas to evaluate PaCO2	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in peak airway pressure	the investigator will record peak airway pressure	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in plateau airway pressure	the investigator will record plateau airway pressure	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in air-trapping	the investigator will record auto-PEEP at the of expiration as a measure of air-trapping	at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
early complications	early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax,	in the first 24 hours from the end of the procedure
late complications	late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.	from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)

Collaborators and Investigators

• Sponsor: University of Genova
• Investigators: Study Director: Paolo Pelosi, Professor, Università degli Studi di Genova; Study Director: Giuseppe Servillo, Professor, Federico II University

Publications and helpful links

General Publications

• Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
• Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8. doi: 10.4065/80.12.1632.
• De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.
• King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002.
• Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0.
• Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.
• Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92. doi: 10.1007/s001340050345.
• Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5.
• Trottier SJ, Hazard PB, Sakabu SA, Levine JH, Troop BR, Thompson JA, McNary R. Posterior tracheal wall perforation during percutaneous dilational tracheostomy: an investigation into its mechanism and prevention. Chest. 1999 May;115(5):1383-9. doi: 10.1378/chest.115.5.1383.
• Campos JH. Update on tracheobronchial anatomy and flexible fiberoptic bronchoscopy in thoracic anesthesia. Curr Opin Anaesthesiol. 2009 Feb;22(1):4-10. doi: 10.1097/ACO.0b013e32831a43ab.
• Vargas M, Pelosi P, Tessitore G, Aloj F, Brunetti I, Arditi E, Salami D, Kacmarek RM, Servillo G. Percutaneous dilatational tracheostomy with a double-lumen endotracheal tube: a comparison of feasibility, gas exchange, and airway pressures. Chest. 2015 May;147(5):1267-1274. doi: 10.1378/chest.14-1465.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): July 3, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Intensive Care Unit; weaning failure; Bedside percutaneous tracheostomy; Dedicated Double-lumen tube; Ineffective Airway Clearance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Nervous System Diseases
• Other Study ID Numbers: 90/12